Literature DB >> 30463849

First CAR to Pass the Road Test: Tisagenlecleucel's Drive to FDA Approval.

Mark B Geyer1,2.   

Abstract

In August 2017, the FDA took historic action in granting the first approval of gene therapy to tisagenlecleucel. This landmark step brought CAR T-cell therapy to the commercial space and heralded a new era in managing refractory B-cell malignancies and FDA oversight of gene-modified therapies.See related article by O'Leary et al., p. 1142. ©2018 American Association for Cancer Research.

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Year:  2018        PMID： 30463849      PMCID： PMC6377838          DOI： 10.1158/1078-0432.CCR-18-3328

Source DB:  PubMed          Journal:  Clin Cancer Res        ISSN： 1078-0432            Impact factor:   12.531


  4 in total

1.  The Next Phase of Human Gene-Therapy Oversight.

Authors:  Francis S Collins; Scott Gottlieb
Journal:  N Engl J Med       Date:  2018-08-15       Impact factor: 91.245

2.  Phase I/Phase II Study of Blinatumomab in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia.

Authors:  Arend von Stackelberg; Franco Locatelli; Gerhard Zugmaier; Rupert Handgretinger; Tanya M Trippett; Carmelo Rizzari; Peter Bader; Maureen M O'Brien; Benoît Brethon; Deepa Bhojwani; Paul Gerhardt Schlegel; Arndt Borkhardt; Susan R Rheingold; Todd Michael Cooper; Christian M Zwaan; Phillip Barnette; Chiara Messina; Gérard Michel; Steven G DuBois; Kuolung Hu; Min Zhu; James A Whitlock; Lia Gore
Journal:  J Clin Oncol       Date:  2016-10-31       Impact factor: 44.544

3.  Tisagenlecleucel in Children and Young Adults with B-Cell Lymphoblastic Leukemia.

Authors:  Shannon L Maude; Theodore W Laetsch; Jochen Buechner; Susana Rives; Michael Boyer; Henrique Bittencourt; Peter Bader; Michael R Verneris; Heather E Stefanski; Gary D Myers; Muna Qayed; Barbara De Moerloose; Hidefumi Hiramatsu; Krysta Schlis; Kara L Davis; Paul L Martin; Eneida R Nemecek; Gregory A Yanik; Christina Peters; Andre Baruchel; Nicolas Boissel; Francoise Mechinaud; Adriana Balduzzi; Joerg Krueger; Carl H June; Bruce L Levine; Patricia Wood; Tetiana Taran; Mimi Leung; Karen T Mueller; Yiyun Zhang; Kapildeb Sen; David Lebwohl; Michael A Pulsipher; Stephan A Grupp
Journal:  N Engl J Med       Date:  2018-02-01       Impact factor: 91.245

4.  FDA Approval Summary: Tisagenlecleucel for Treatment of Patients with Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia.

Authors:  Maura C O'Leary; Xiaobin Lu; Ying Huang; Xue Lin; Iftekhar Mahmood; Donna Przepiorka; Denise Gavin; Shiowjen Lee; Ke Liu; Bindu George; Wilson Bryan; Marc R Theoret; Richard Pazdur
Journal:  Clin Cancer Res       Date:  2018-10-11       Impact factor: 12.531
  4 in total
  10 in total

Review 1.  Epithelial Ovarian Cancer and the Immune System: Biology, Interactions, Challenges and Potential Advances for Immunotherapy.

Authors:  Anne M Macpherson; Simon C Barry; Carmela Ricciardelli; Martin K Oehler
Journal:  J Clin Med       Date:  2020-09-14       Impact factor: 4.241

Review 2.  Bispecific T-Cell Redirection versus Chimeric Antigen Receptor (CAR)-T Cells as Approaches to Kill Cancer Cells.

Authors:  William R Strohl; Michael Naso
Journal:  Antibodies (Basel)       Date:  2019-07-03

Review 3.  The model of cytokine release syndrome in CAR T-cell treatment for B-cell non-Hodgkin lymphoma.

Authors:  Jianshu Wei; Yang Liu; Chunmeng Wang; Yajing Zhang; Chuan Tong; Guanghai Dai; Wei Wang; John E J Rasko; J Joseph Melenhorst; Wenbin Qian; Aibin Liang; Weidong Han
Journal:  Signal Transduct Target Ther       Date:  2020-07-29

4.  Inflammatory signatures for quick diagnosis of life-threatening infection during the CAR T-cell therapy.

Authors:  Hui Luo; Na Wang; Liang Huang; Xiaoxi Zhou; Jin Jin; Chunrei Li; Di Wang; Bin Xu; Jinhuan Xu; Lijun Jiang; Jue Wang; Yang Cao; Yi Xiao; Qian Zhang; Xia Mao; Songya Liu; Liting Chen; Min Xiao; Jianfeng Zhou
Journal:  J Immunother Cancer       Date:  2019-10-22       Impact factor: 13.751

Review 5.  The Application of Nanobody in CAR-T Therapy.

Authors:  Chaolemeng Bao; Quanli Gao; Lin-Lin Li; Lu Han; Bingxiang Zhang; Yijin Ding; Zongpei Song; Ruining Zhang; Jishuai Zhang; Xian-Hui Wu
Journal:  Biomolecules       Date:  2021-02-08

Review 6.  Focused evaluation of the roles of macrophages in chimeric antigen receptor (CAR) T cell therapy associated cytokine release syndrome.

Authors:  Hanfei Guo; Lei Qian; Jiuwei Cui
Journal:  Cancer Biol Med       Date:  2021-09-28       Impact factor: 4.248

Review 7.  Bispecific Antibodies in Cancer Immunotherapy: A Novel Response to an Old Question.

Authors:  Camila Ordóñez-Reyes; Juan Esteban Garcia-Robledo; Diego F Chamorro; Andrés Mosquera; Liliana Sussmann; Alejandro Ruiz-Patiño; Oscar Arrieta; Lucia Zatarain-Barrón; Leonardo Rojas; Alessandro Russo; Diego de Miguel-Perez; Christian Rolfo; Andrés F Cardona
Journal:  Pharmaceutics       Date:  2022-06-11       Impact factor: 6.525

8.  Exosome-mediated delivery of RNA and DNA for gene therapy.

Authors:  Radha Munagala; Farrukh Aqil; Jeyaprakash Jeyabalan; Raghuram Kandimalla; Margaret Wallen; Neha Tyagi; Sarah Wilcher; Jun Yan; David J Schultz; Wendy Spencer; Ramesh C Gupta
Journal:  Cancer Lett       Date:  2021-02-18       Impact factor: 8.679

Review 9.  Clinical development of CAR T cell therapy in China: 2020 update.

Authors:  Jianshu Wei; Yelei Guo; Yao Wang; Zhiqiang Wu; Jian Bo; Bin Zhang; Jun Zhu; Weidong Han
Journal:  Cell Mol Immunol       Date:  2020-09-30       Impact factor: 11.530

10.  Versatile chimeric antigen receptor platform for controllable and combinatorial T cell therapy.

Authors:  Anja Feldmann; Anja Hoffmann; Ralf Bergmann; Stefanie Koristka; Nicole Berndt; Claudia Arndt; Liliana Rodrigues Loureiro; Enrico Kittel-Boselli; Nicola Mitwasi; Alexandra Kegler; Chris Lamprecht; Karla Elizabeth González Soto; Michael Bachmann
Journal:  Oncoimmunology       Date:  2020-07-03       Impact factor: 8.110
  10 in total

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